NCT04404725已完成不适用
Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 14
- 主要终点
- Ease of Lens Handling at Insertion
研究概览
简要总结
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.
详细描述
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 42 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Self reports having a full eye examination in the previous two years;
- •Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Habitually wears soft contact lens for the past 3 months minimum;
- •Has refractive astigmatism of at least -0.75DC;
- •Is presbyopic and requires a reading addition of at least +0.75D;
- •Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (sphere +4 to -6; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50).
排除标准
- •Is participating in any concurrent clinical or research study;
- •Habitually wears one of the study contact lenses;
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
- •Has known sensitivity to the diagnostic sodium fluorescein and/or the care product Opti-Free PureMoist being used in the study;
- •Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
- •Has undergone refractive error surgery. * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
结局指标
主要结局
Ease of Lens Handling at Insertion
时间窗: Day 28
Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy).
次要结局
未报告次要终点
研究者
研究点 (14)
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